Articles tagged with “drug-recall”

SmPC Translation: How Errors Lead to Drug Recall Risks

Learn how pharmaceutical translation errors in SmPCs and patient leaflets lead to drug recalls, regulatory sanctions, and patient safety risks. Updated with 2025-2026 EU pharma legislation reform, EMA ePI roadmap, and AI translation developments.

50 min read

11/22/2025

pharmaceutical translation smpc drug recall labeling errors regulatory affairs patient safety ema patient information leaflet